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Study in Participants With Acute Migraines Headaches

A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00804973
Enrollment
120
Registered
2008-12-09
Start date
2008-11-30
Completion date
2009-05-31
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Headache

Keywords

Migraine, Headache

Brief summary

This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.

Interventions

DRUGLY2590443

200 milligrams (mg) as four 50-mg capsules, oral, once

DRUGPlacebo injection

saline solution, injection, once

DRUGSumatriptan

6 milligrams (mg) injection (0.5 milliliter \[mL\] of 12 mg/mL solution), once

DRUGPlacebo capsule

4 capsules, once

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female participants between the ages of 18 and 65 years, inclusive. * Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year. * Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month). * Participants who are willing and able to comply with the study schedule and requirements. * Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent. * Participants who in the opinion of the principal investigator are in good general health. * Venous access should be sufficient to allow blood sampling as per protocol.

Exclusion criteria

* Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator). * Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding. * History or presence of significant medical illnesses as determined by the investigator. * Participants with a current clinical diagnosis of major psychiatric disease. * Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible. * Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study. * Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor. * Are unwilling or unable to comply with the use of a diary to directly record data from the participant.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Headache Pain Free Response2 hours after study drug administrationParticipants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Headache pain free response was defined as the number of participants with a migraine pain intensity score of none.

Secondary

MeasureTime frameDescription
Number of Participants With Pain Relief Response30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain relief response was defined as the number of participants with a migraine pain intensity score of none.
Number of Participants With Sustained Pain Relief Response24 and 48 hours after study drug administrationParticipants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain relief response was defined as the number of participants with no return of a moderate or severe headache after pain went down to mild or none at 2 hours.
Number of Participants With Recurrent Migraine Headache Within 24 or 48 HoursUp to 24 and 48 hours after study drug administrationThe time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug.
Number of Participants With NauseaPre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.The number of participants reporting nausea as a migraine symptom
Number of Participants With Pain Free Response30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administrationParticipants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain free response was defined as the number of participants with a migraine pain intensity score of none.
Number of Participants With PhotophobiaPre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.The number of participants reporting photophobia as a migraine symptom
Number of Participants With VomitingPre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.The number of participants reporting vomiting as a migraine symptom
Number of Participants With Sustained Pain Free Response24 and 48 hours after study drug administrationParticipants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain free response was defined as the number of participants with no return of a mild, moderate or severe headache after pain intensity went down to none at 2 hours.
Number of Participants With PhonophobiaPre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.The number of participants reporting phonophobia as a migraine symptom

Countries

United States

Participant flow

Participants by arm

ArmCount
LY2590443
200 milligrams (mg) administered once as four 50-mg capsules
40
Sumatriptan
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
40
Placebo
Administered once as 4 capsules or once as an injection of saline solution
40
Total120

Baseline characteristics

CharacteristicLY2590443TotalPlaceboSumatriptan
Age, Continuous40.30 years
STANDARD_DEVIATION 12.4
39.10 years
STANDARD_DEVIATION 11.98
37.48 years
STANDARD_DEVIATION 10.58
39.53 years
STANDARD_DEVIATION 12.94
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants15 Participants7 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants105 Participants33 Participants36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants27 Participants7 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants7 Participants1 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants1 Participants2 Participants
Race (NIH/OMB)
White
25 Participants78 Participants29 Participants24 Participants
Region of Enrollment
United States
40 Participants120 Participants40 Participants40 Participants
Sex: Female, Male
Female
28 Participants83 Participants29 Participants26 Participants
Sex: Female, Male
Male
12 Participants37 Participants11 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
13 / 4016 / 403 / 40
serious
Total, serious adverse events
0 / 400 / 400 / 40

Outcome results

Primary

Number of Participants With Headache Pain Free Response

Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Headache pain free response was defined as the number of participants with a migraine pain intensity score of none.

Time frame: 2 hours after study drug administration

Population: All participants who received at least 1 dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Headache Pain Free Response6 Participants
SumatriptanNumber of Participants With Headache Pain Free Response12 Participants
PlaceboNumber of Participants With Headache Pain Free Response6 Participants
Secondary

Number of Participants With Nausea

The number of participants reporting nausea as a migraine symptom

Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Nausea30 Minutes Post-dose13 Participants
LY2590443Number of Participants With Nausea2 Hours Post-dose8 Participants
LY2590443Number of Participants With Nausea1.5 Hours Post-dose8 Participants
LY2590443Number of Participants With NauseaPre-Dose18 Participants
LY2590443Number of Participants With Nausea4 Hours Post-dose4 Participants
LY2590443Number of Participants With Nausea3 Hours Post-dose6 Participants
LY2590443Number of Participants With Nausea1 Hour Post-dose13 Participants
SumatriptanNumber of Participants With Nausea1.5 Hours Post-dose10 Participants
SumatriptanNumber of Participants With NauseaPre-Dose16 Participants
SumatriptanNumber of Participants With Nausea30 Minutes Post-dose19 Participants
SumatriptanNumber of Participants With Nausea1 Hour Post-dose13 Participants
SumatriptanNumber of Participants With Nausea2 Hours Post-dose8 Participants
SumatriptanNumber of Participants With Nausea3 Hours Post-dose7 Participants
SumatriptanNumber of Participants With Nausea4 Hours Post-dose4 Participants
PlaceboNumber of Participants With Nausea2 Hours Post-dose6 Participants
PlaceboNumber of Participants With Nausea30 Minutes Post-dose19 Participants
PlaceboNumber of Participants With Nausea4 Hours Post-dose2 Participants
PlaceboNumber of Participants With Nausea3 Hours Post-dose3 Participants
PlaceboNumber of Participants With Nausea1.5 Hours Post-dose8 Participants
PlaceboNumber of Participants With Nausea1 Hour Post-dose12 Participants
PlaceboNumber of Participants With NauseaPre-Dose25 Participants
Secondary

Number of Participants With Pain Free Response

Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain free response was defined as the number of participants with a migraine pain intensity score of none.

Time frame: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Pain Free Response3 Hours Post-dose14 Participants
LY2590443Number of Participants With Pain Free Response1.5 Hours Post-dose3 Participants
LY2590443Number of Participants With Pain Free Response30 Minutes Post-dose7 Participants
LY2590443Number of Participants With Pain Free Response1 Hour Post-dose1 Participants
LY2590443Number of Participants With Pain Free Response4 Hours Post-dose25 Participants
SumatriptanNumber of Participants With Pain Free Response1.5 Hours Post-dose10 Participants
SumatriptanNumber of Participants With Pain Free Response30 Minutes Post-dose8 Participants
SumatriptanNumber of Participants With Pain Free Response1 Hour Post-dose5 Participants
SumatriptanNumber of Participants With Pain Free Response3 Hours Post-dose19 Participants
SumatriptanNumber of Participants With Pain Free Response4 Hours Post-dose30 Participants
PlaceboNumber of Participants With Pain Free Response4 Hours Post-dose24 Participants
PlaceboNumber of Participants With Pain Free Response3 Hours Post-dose13 Participants
PlaceboNumber of Participants With Pain Free Response30 Minutes Post-dose4 Participants
PlaceboNumber of Participants With Pain Free Response1.5 Hours Post-dose5 Participants
PlaceboNumber of Participants With Pain Free Response1 Hour Post-dose2 Participants
Secondary

Number of Participants With Pain Relief Response

Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain relief response was defined as the number of participants with a migraine pain intensity score of none.

Time frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Pain Relief Response30 Minutes Post-dose7 Participants
LY2590443Number of Participants With Pain Relief Response1 Hour Post-dose11 Participants
LY2590443Number of Participants With Pain Relief Response1.5 Hours Post-dose17 Participants
LY2590443Number of Participants With Pain Relief Response2 Hours Post-dose22 Participants
LY2590443Number of Participants With Pain Relief Response3 Hours Post-dose34 Participants
LY2590443Number of Participants With Pain Relief Response4 Hours Post-dose38 Participants
SumatriptanNumber of Participants With Pain Relief Response4 Hours Post-dose39 Participants
SumatriptanNumber of Participants With Pain Relief Response30 Minutes Post-dose8 Participants
SumatriptanNumber of Participants With Pain Relief Response2 Hours Post-dose31 Participants
SumatriptanNumber of Participants With Pain Relief Response3 Hours Post-dose35 Participants
SumatriptanNumber of Participants With Pain Relief Response1 Hour Post-dose14 Participants
SumatriptanNumber of Participants With Pain Relief Response1.5 Hours Post-dose25 Participants
PlaceboNumber of Participants With Pain Relief Response1 Hour Post-dose12 Participants
PlaceboNumber of Participants With Pain Relief Response1.5 Hours Post-dose18 Participants
PlaceboNumber of Participants With Pain Relief Response4 Hours Post-dose34 Participants
PlaceboNumber of Participants With Pain Relief Response2 Hours Post-dose24 Participants
PlaceboNumber of Participants With Pain Relief Response30 Minutes Post-dose4 Participants
PlaceboNumber of Participants With Pain Relief Response3 Hours Post-dose35 Participants
Secondary

Number of Participants With Phonophobia

The number of participants reporting phonophobia as a migraine symptom

Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Phonophobia30 Minutes Post-dose24 Participants
LY2590443Number of Participants With Phonophobia2 Hours Post-dose11 Participants
LY2590443Number of Participants With Phonophobia1.5 Hours Post-dose15 Participants
LY2590443Number of Participants With PhonophobiaPre-Dose28 Participants
LY2590443Number of Participants With Phonophobia4 Hours Post-dose4 Participants
LY2590443Number of Participants With Phonophobia3 Hours Post-dose6 Participants
LY2590443Number of Participants With Phonophobia1 Hour Post-dose19 Participants
SumatriptanNumber of Participants With Phonophobia1.5 Hours Post-dose18 Participants
SumatriptanNumber of Participants With PhonophobiaPre-Dose33 Participants
SumatriptanNumber of Participants With Phonophobia30 Minutes Post-dose25 Participants
SumatriptanNumber of Participants With Phonophobia1 Hour Post-dose20 Participants
SumatriptanNumber of Participants With Phonophobia2 Hours Post-dose13 Participants
SumatriptanNumber of Participants With Phonophobia3 Hours Post-dose3 Participants
SumatriptanNumber of Participants With Phonophobia4 Hours Post-dose1 Participants
PlaceboNumber of Participants With Phonophobia2 Hours Post-dose12 Participants
PlaceboNumber of Participants With Phonophobia30 Minutes Post-dose26 Participants
PlaceboNumber of Participants With Phonophobia4 Hours Post-dose3 Participants
PlaceboNumber of Participants With Phonophobia3 Hours Post-dose5 Participants
PlaceboNumber of Participants With Phonophobia1.5 Hours Post-dose16 Participants
PlaceboNumber of Participants With Phonophobia1 Hour Post-dose22 Participants
PlaceboNumber of Participants With PhonophobiaPre-Dose31 Participants
Secondary

Number of Participants With Photophobia

The number of participants reporting photophobia as a migraine symptom

Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Photophobia30 Minutes Post-dose33 Participants
LY2590443Number of Participants With Photophobia2 Hours Post-dose22 Participants
LY2590443Number of Participants With Photophobia1.5 Hours Post-dose25 Participants
LY2590443Number of Participants With PhotophobiaPre-Dose38 Participants
LY2590443Number of Participants With Photophobia4 Hours Post-dose6 Participants
LY2590443Number of Participants With Photophobia3 Hours Post-dose12 Participants
LY2590443Number of Participants With Photophobia1 Hour Post-dose31 Participants
SumatriptanNumber of Participants With Photophobia1.5 Hours Post-dose23 Participants
SumatriptanNumber of Participants With PhotophobiaPre-Dose37 Participants
SumatriptanNumber of Participants With Photophobia30 Minutes Post-dose31 Participants
SumatriptanNumber of Participants With Photophobia1 Hour Post-dose28 Participants
SumatriptanNumber of Participants With Photophobia2 Hours Post-dose19 Participants
SumatriptanNumber of Participants With Photophobia3 Hours Post-dose9 Participants
SumatriptanNumber of Participants With Photophobia4 Hours Post-dose4 Participants
PlaceboNumber of Participants With Photophobia2 Hours Post-dose24 Participants
PlaceboNumber of Participants With Photophobia30 Minutes Post-dose36 Participants
PlaceboNumber of Participants With Photophobia4 Hours Post-dose6 Participants
PlaceboNumber of Participants With Photophobia3 Hours Post-dose10 Participants
PlaceboNumber of Participants With Photophobia1.5 Hours Post-dose27 Participants
PlaceboNumber of Participants With Photophobia1 Hour Post-dose31 Participants
PlaceboNumber of Participants With PhotophobiaPre-Dose38 Participants
Secondary

Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours

The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug.

Time frame: Up to 24 and 48 hours after study drug administration

Population: All participants who received at least 1 dose of study drug with evaluable migraine recurrence data.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours24 Hours Post-dose2 Participants
LY2590443Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours48 Hours Post-dose6 Participants
SumatriptanNumber of Participants With Recurrent Migraine Headache Within 24 or 48 Hours24 Hours Post-dose2 Participants
SumatriptanNumber of Participants With Recurrent Migraine Headache Within 24 or 48 Hours48 Hours Post-dose4 Participants
PlaceboNumber of Participants With Recurrent Migraine Headache Within 24 or 48 Hours24 Hours Post-dose4 Participants
PlaceboNumber of Participants With Recurrent Migraine Headache Within 24 or 48 Hours48 Hours Post-dose6 Participants
Secondary

Number of Participants With Sustained Pain Free Response

Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain free response was defined as the number of participants with no return of a mild, moderate or severe headache after pain intensity went down to none at 2 hours.

Time frame: 24 and 48 hours after study drug administration

Population: All participants who received at least 1 dose of study drug and had Sustained Pain Free Response data.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Sustained Pain Free ResponsePain Free at 24 Hours Post-dose5 Participants
LY2590443Number of Participants With Sustained Pain Free ResponsePain Free at 48 Hours Post-dose5 Participants
SumatriptanNumber of Participants With Sustained Pain Free ResponsePain Free at 24 Hours Post-dose11 Participants
SumatriptanNumber of Participants With Sustained Pain Free ResponsePain Free at 48 Hours Post-dose9 Participants
PlaceboNumber of Participants With Sustained Pain Free ResponsePain Free at 24 Hours Post-dose6 Participants
PlaceboNumber of Participants With Sustained Pain Free ResponsePain Free at 48 Hours Post-dose6 Participants
Secondary

Number of Participants With Sustained Pain Relief Response

Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain relief response was defined as the number of participants with no return of a moderate or severe headache after pain went down to mild or none at 2 hours.

Time frame: 24 and 48 hours after study drug administration

Population: All participants who received at least 1 dose of study drug and had Sustained Pain Relief Response data.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Sustained Pain Relief ResponsePain Relief at 24 Hrs Post-dose19 Participants
LY2590443Number of Participants With Sustained Pain Relief ResponsePain Relief at 48 Hrs Post-dose19 Participants
SumatriptanNumber of Participants With Sustained Pain Relief ResponsePain Relief at 24 Hrs Post-dose28 Participants
SumatriptanNumber of Participants With Sustained Pain Relief ResponsePain Relief at 48 Hrs Post-dose27 Participants
PlaceboNumber of Participants With Sustained Pain Relief ResponsePain Relief at 24 Hrs Post-dose24 Participants
PlaceboNumber of Participants With Sustained Pain Relief ResponsePain Relief at 48 Hrs Post-dose23 Participants
Secondary

Number of Participants With Vomiting

The number of participants reporting vomiting as a migraine symptom

Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Population: All participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LY2590443Number of Participants With Vomiting30 Minutes Post-dose0 Participants
LY2590443Number of Participants With Vomiting2 Hours Post-dose1 Participants
LY2590443Number of Participants With Vomiting1.5 Hours Post-dose1 Participants
LY2590443Number of Participants With VomitingPre-Dose1 Participants
LY2590443Number of Participants With Vomiting4 Hours Post-dose0 Participants
LY2590443Number of Participants With Vomiting3 Hours Post-dose0 Participants
LY2590443Number of Participants With Vomiting1 Hour Post-dose1 Participants
SumatriptanNumber of Participants With Vomiting1.5 Hours Post-dose1 Participants
SumatriptanNumber of Participants With VomitingPre-Dose1 Participants
SumatriptanNumber of Participants With Vomiting30 Minutes Post-dose2 Participants
SumatriptanNumber of Participants With Vomiting1 Hour Post-dose1 Participants
SumatriptanNumber of Participants With Vomiting2 Hours Post-dose0 Participants
SumatriptanNumber of Participants With Vomiting3 Hours Post-dose0 Participants
SumatriptanNumber of Participants With Vomiting4 Hours Post-dose0 Participants
PlaceboNumber of Participants With Vomiting2 Hours Post-dose0 Participants
PlaceboNumber of Participants With Vomiting30 Minutes Post-dose1 Participants
PlaceboNumber of Participants With Vomiting4 Hours Post-dose0 Participants
PlaceboNumber of Participants With Vomiting3 Hours Post-dose0 Participants
PlaceboNumber of Participants With Vomiting1.5 Hours Post-dose0 Participants
PlaceboNumber of Participants With Vomiting1 Hour Post-dose0 Participants
PlaceboNumber of Participants With VomitingPre-Dose2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026